12 January 2012 - CSL Behring, a plasma protein therapeutics firm owned by Australian CSL Ltd (ASX:CSL), said today it had kicked off its global Phase II/III multi-centre study designed to assess the safety, efficacy and pharmacokinetics of recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP).

The prospective, open-label trial will recruit patients aged 12 to 65 with haemophilia B.

The first study site is located in Vienna.

CSL Behring, with the help of its parent, is developing rIX-FP for the prophylaxis and treatment of bleeds in patients with congenital Factor IX (FIX) deficiency as part of the PROLONG-9FP clinical study programme.

Until now, the PROLONG-9FP programme has established trial sites in Austria, France, Bulgaria, Germany, Italy, Spain and Israel with additional trial sites to be initiated shortly in the US, Japan and Russia.

The Phase II/III trial includes a screening period, a pharmacokinetic (PK) evaluation, followed by around 12-month safety and efficacy assessment with rIX-FP.  It also includes a surgical prophylaxis sub-trial.